Atherectomy Devices and intravascUlAr Lithotripsy

Conditions

ischemic heart disease Calcified lesion, atherectomy, intravascular lithotripsy

Sotomi Y, Kuriyama N, Tanaka Y, Yamazaki S, Kawasaki T, Kadota K, Muramatsu T, Takahashi A, Ashikaga T, Ando K, Otsuji S, Ishida M, Nakamura S, Ito Y, Iijima R, Nakazawa G, Shite J, Honye J, Ako J, Yokoi H, Kozuma K, Otake H, Yamada T, Nakamura M.

2026-07-08

10.1161/circinterventions.126.016686

Dual-Prep registry: Atherectomy devices and intravascUlAr lithotripsy for the PREParation of heavily calcified coronary lesions registry, 1-year results

M Nakamura, Nehiro Kuriyama, Yutaka Tanaka, Seiji Yamazaki, T Kawasaki et al. (25 authors)

Cardiovascular Intervention and Therapeutics2026-03-19

10.1007/s12928-026-01264-4

Dual-Prep registry: atherectomy Devices and intravascUlAr Lithotripsy for the PREParation of heavily calcified coronary lesions registry, 1-year Results

Masato Nakamura, Nehiro Kiriyama, Yutaka Tanaka, Seiji Yamazaki, Tomohiro Kawasaki et al. (25 authors)

2025-12-20

10.64898/2025.12.17.25342522

Dual-Prep registry: atherectomy devices and intravascUlAr lithotripsy for the PREParation of heavily calcified coronary lesions registry.

Nakamura M, Kuriyama N, Tanaka Y, Yamazaki S, Kawasaki T, Muramatsu T, Kadota K, Ashikaga T, Takahashi A, Otsuji S, Ando K, Ishida M, Nakamura S, Ito Y, Iijima R, Nakazawa G, Shite J, Honye J, Ako J, Yokoi H, Kozuma K, Otake H, Masumura K, Yamada T, Sotomi Y.

2025-05-126 citations

10.1007/s12928-025-01130-9

Interventions

none

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.More than 18 years of age 2.Patients with heavily calcified lesions* for which treatment with the IVL System in combination with other atherectomy devices is deemed desirable based on angiographic findings or clinical determination.

Exclusion criteria

Exclusion criteria: 1. Patients on follow-up from this study, or who are participating/may participate in another clinical study that may affect the results of this study. 2. Patients who are ineligible for treatment with the investigational device

Design outcomes

Primary

Measure	Time frame
Safety The primary safety endpoint is to evaluate freedom rate from major adverse cardiac events (MACE) within 30 days of the index study procedure. MACE is defined as the composite occurrence of: -cardiac death myocardial Infarction (MI): MI within 48 hours after procedure, as defined by the Society for Cardiovascular Angiography and Interventions (SCAI), and spontaneous MI after 48 hours, as defined by the Fourth Universal Definition of Myocardial Infarction. -revascularization of target vessels (TVR) (including target lesions) The independent Clinical Evaluation Committee will determine all possible MACE events. Efficacy The primary efficacy endpoint is procedural success defined by less than 50% residual stenosis after stent implantation (by angiographic assessment in the core laboratory) and freedom from in-hospital MACE.	—

Measure

Time frame

Safety The primary safety endpoint is to evaluate freedom rate from major adverse cardiac events (MACE) within 30 days of the index study procedure. MACE is defined as the composite occurrence of: -cardiac death myocardial Infarction (MI): MI within 48 hours after procedure, as defined by the Society for Cardiovascular Angiography and Interventions (SCAI), and spontaneous MI after 48 hours, as defined by the Fourth Universal Definition of Myocardial Infarction. -revascularization of target vessels (TVR) (including target lesions) The independent Clinical Evaluation Committee will determine all possible MACE events. Efficacy The primary efficacy endpoint is procedural success defined by less than 50% residual stenosis after stent implantation (by angiographic assessment in the core laboratory) and freedom from in-hospital MACE.

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Secondary

Measure	Time frame
At 12 months after procedures MACE includes 1. Death(All death, Cardiac death, Non cardiac death) 2. MI(All MI TV-MI, non-TV-MI, Q-wave and non-Q-wave) 3. Procedural MI( SCAI definition and CK-MB level more than 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave at discharge (periprocedural MI) and more than 48 hours after discharge using the Fourth Universal Definition of Myocardial Infarction beyond discharge (spontaneous MI) 4. Revascularization (All revascularization, ID-TLR, ID-TVR, ID-TV-non-TLR, ID-non-TVR) Stent thrombosis 1. definite, probable, definite + probable by Academic Research Consortium -2 definition Target lesion failure (TLF) includes 1. cardiac death, target vessel related MI (Q-wave and non-Q-wave), or ID-TLR by percutaneous or surgical methods. Serious angiographic complications defined as 1. severe dissection (Type D to F) 2. perforation, acute occlusion 3. persistent slow flow or no reflow Device crossing success, Procedural success and Angiographic success 1. Device crossing success, defined as the ability to deliver the IVL catheter across the target lesion, without serious angiographic complications immediately after coronary lithotripsy using IVL System 2. Procedural success defined by less than 50% residual stenosis after stent implantation (by angiographic assessment in the core laboratory) and freedom from in-hospital MACE. 3. Angiographic success, defined as greater tahn 30% residual stenosis after stent implantation and without serious angiographic complications 4. Procedural success, defined as greater than 30% residual stenosis after stent implantation (by angiographic assessment in the core laboratory) and freedom from in-hospital MACE Highly calcified lesion treatment information during the period of enrollment in this study 1. Frequency of use of atherectomy devices and IVL systems in highly calcified lesions	—

Measure

Time frame

At 12 months after procedures MACE includes 1. Death(All death, Cardiac death, Non cardiac death) 2. MI(All MI TV-MI, non-TV-MI, Q-wave and non-Q-wave) 3. Procedural MI( SCAI definition and CK-MB level more than 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave at discharge (periprocedural MI) and more than 48 hours after discharge using the Fourth Universal Definition of Myocardial Infarction beyond discharge (spontaneous MI) 4. Revascularization (All revascularization, ID-TLR, ID-TVR, ID-TV-non-TLR, ID-non-TVR) Stent thrombosis 1. definite, probable, definite + probable by Academic Research Consortium -2 definition Target lesion failure (TLF) includes 1. cardiac death, target vessel related MI (Q-wave and non-Q-wave), or ID-TLR by percutaneous or surgical methods. Serious angiographic complications defined as 1. severe dissection (Type D to F) 2. perforation, acute occlusion 3. persistent slow flow or no reflow Device crossing success, Procedural success and Angiographic success 1. Device crossing success, defined as the ability to deliver the IVL catheter across the target lesion, without serious angiographic complications immediately after coronary lithotripsy using IVL System 2. Procedural success defined by less than 50% residual stenosis after stent implantation (by angiographic assessment in the core laboratory) and freedom from in-hospital MACE. 3. Angiographic success, defined as greater tahn 30% residual stenosis after stent implantation and without serious angiographic complications 4. Procedural success, defined as greater than 30% residual stenosis after stent implantation (by angiographic assessment in the core laboratory) and freedom from in-hospital MACE Highly calcified lesion treatment information during the period of enrollment in this study 1. Frequency of use of atherectomy devices and IVL systems in highly calcified lesions

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Contacts

Public ContactNoriko Kawaharada

Micron,.Inc.

dual-prep@micron-kobe.com81-03-6631-3696

Outcome results

None listed